Clinical Trials List
Protocol Number20230050 (HZNP-DAZ-304)
NCT Number(ClinicalTrials.gov Identfier)NCT06747949
Active
2025-09-01 - 2029-12-31
Recruiting5
ICD-10M35.00
Sicca syndrome, unspecified
ICD-10M35.01
Sicca syndrome with keratoconjunctivitis
ICD-10M35.09
Sicca syndrome with other organ involvement
ICD-9710.2
Sicca syndrome
A multicenter, open-label, long-term, extended trial was conducted to evaluate the safety and tolerability of Dazodalibep in participants with Schugel's syndrome (SS).
-
Sponsor
Thermo fisher Co., Ltd. Taiwan Branch
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/07/21
Investigators and Locations
Co-Principal Investigator
- 謝祖怡 Division of Rheumatology
- 謝佳偉 Division of Rheumatology
- Yi-Hsing Chen Division of Rheumatology
- WEN-NAN HUANG Division of Rheumatology
- Yi-Ming Chen Division of Rheumatology
- 林靖才 Division of Rheumatology
- 陳彥如 Division of Rheumatology
- 廖育婉 Division of Rheumatology
- 顏在弘 Division of Rheumatology
- 高宗楙 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tzn-Min Lin Division of Rheumatology
- 林科宏 Division of Rheumatology
- 李向嚴 Division of Rheumatology
- 林韋睿 Division of Rheumatology
- 張克宇 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
- 黃建中 風濕免疫科
- 張詩欣 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jeng-Hsien Yen 風濕免疫科
- 歐燦騰 風濕免疫科
- Chia-Chun Tseng 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yao-Fan Fang
Co-Principal Investigator
- Shue-Fen Lo Division of Rheumatology
- Ping-Han Tsai Division of Rheumatology
- 陳彥輔 Division of Rheumatology
- 張哲慈 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Incidence of treatment-induced adverse events (TEAEs), treatment-induced serious adverse events (TESAEs), and adverse events of particular concern (AESIs).
Objectives
Primary Objective: To evaluate the long-term safety and tolerability of Dazodalibep.
Secondary Objective: To evaluate the immunogenicity of long-term administration of Dazodalibep in participants with SS.
To analyze the pharmacokinetic characteristics of Dazodalibep in participants with SS.
Test Drug
Dazodalibep
Active Ingredient
dazodalibep
Dosage Form
Injectable
Dosage
1500 mg/15mL
Endpoints
Incidence of treatment-induced adverse events (TEAEs), treatment-induced serious adverse events (TESAEs), and adverse events of particular concern (AESIs).
Inclution Criteria
Participants are eligible for this trial only if they meet all of the following criteria:
1. Participants have provided subject consent prior to the commencement of any trial-specific activity/procedure.
2. Participants must be eligible to receive and have already received the investigational drug (dazodalibep or placebo) and have completed (up to week 48) one of the Phase 3 SS dazodalibep trials (HZNP-DAZ-301 or HZNP-DAZ-303).
Note: Participants who prematurely discontinue the investigational drug are ineligible for this trial.
3. Participants must be able to receive the first dose of this Long-Term Extension (LTE) trial at their previous pivotal Phase 3 SS dazodalibep trial (HZNP-DAZ-301 or HZNP-DAZ-303) at their week 48 follow-up visit (+28 days).
Note: Participants may be enrolled after their 48th week follow-up visit (+28 days) subject to approval by an Amgen health monitor.
Send feedback
1. Participants have provided subject consent prior to the commencement of any trial-specific activity/procedure.
2. Participants must be eligible to receive and have already received the investigational drug (dazodalibep or placebo) and have completed (up to week 48) one of the Phase 3 SS dazodalibep trials (HZNP-DAZ-301 or HZNP-DAZ-303).
Note: Participants who prematurely discontinue the investigational drug are ineligible for this trial.
3. Participants must be able to receive the first dose of this Long-Term Extension (LTE) trial at their previous pivotal Phase 3 SS dazodalibep trial (HZNP-DAZ-301 or HZNP-DAZ-303) at their week 48 follow-up visit (+28 days).
Note: Participants may be enrolled after their 48th week follow-up visit (+28 days) subject to approval by an Amgen health monitor.
Send feedback
Exclusion Criteria
Participants are ineligible to participate in this trial if they meet any of the following criteria:
Other Medical Conditions
1. Clinically significant active infection identified by the trial administrator on day 1, including persistent and chronic infections requiring antibiotic or antiviral treatment.
Previous/Concurrent Clinical Trial Experience
2. Planned participation in another clinical trial of the investigational drug or procedure during the LTE trial. Participants undergoing other experimental procedures or participating in observational studies during this trial will be excluded.
Other Exclusion Criteria
3. Any health condition or change observed or reported during the Phase 3 SS trial (HZNP-DAZ-301 or HZNP-DAZ-303) that, in the judgment of the trial administrator or trial sponsor, would interfere with the assessment and interpretation of participant safety or alter the risk-benefit relationship associated with administration of the investigational drug (including laboratory tests performed at week 44 of a previous Phase 3 trial).
4. Planned surgery or hospitalization that, in the judgment of the trial administrator or trial sponsor, would interfere with the assessment and interpretation of participant safety. 5. Plans to receive a live (attenuated) vaccine during the LTE trial.
6. Female participants of childbearing potential who are unwilling to use the contraceptive method specified in the trial protocol during treatment and for an additional 12 weeks after receiving the last dose of the investigational drug.
7. Female participants who are breastfeeding or plan to breastfeed during the trial and for 12 weeks after receiving the last dose of the investigational drug.
8. Female participants who plan to become pregnant or donate eggs during the trial and for 12 weeks after receiving the last dose of the investigational drug.
9. Female participants of childbearing potential who have a positive pregnancy assessment result on day 1 of a high-sensitivity urine pregnancy test.
10. Male participants with a female partner of childbearing potential who are unwilling to abstain from sexual intercourse (avoiding heterosexual activity) or use contraception during treatment and for an additional 12 weeks after receiving the last dose of the investigational drug.
11. Male participants with a pregnant partner who are unwilling to abstain from sexual intercourse or use condoms during treatment and for an additional 12 weeks after receiving the last dose of the investigational drug.
12. Male participants who do not wish to avoid sperm donation during treatment and for an additional 12 weeks after receiving the last dose of the investigational drug.
13. Participants with a known allergy to any drug or ingredient administered during the treatment period.
14. Participants who, to the best of the participant's and the trial administrator's knowledge, may be unable to complete all trial follow-up visits or procedures required by the trial protocol, and/or comply with all necessary trial procedures (e.g., clinical outcome assessment).
15. Any other clinically significant medical history, condition, or disease (other than those listed above) that, in the judgment of the trial administrator or Amgen physician (if consulted), poses a risk to the participant's safety or interferes with trial assessment, procedures, or completion.
Other Medical Conditions
1. Clinically significant active infection identified by the trial administrator on day 1, including persistent and chronic infections requiring antibiotic or antiviral treatment.
Previous/Concurrent Clinical Trial Experience
2. Planned participation in another clinical trial of the investigational drug or procedure during the LTE trial. Participants undergoing other experimental procedures or participating in observational studies during this trial will be excluded.
Other Exclusion Criteria
3. Any health condition or change observed or reported during the Phase 3 SS trial (HZNP-DAZ-301 or HZNP-DAZ-303) that, in the judgment of the trial administrator or trial sponsor, would interfere with the assessment and interpretation of participant safety or alter the risk-benefit relationship associated with administration of the investigational drug (including laboratory tests performed at week 44 of a previous Phase 3 trial).
4. Planned surgery or hospitalization that, in the judgment of the trial administrator or trial sponsor, would interfere with the assessment and interpretation of participant safety. 5. Plans to receive a live (attenuated) vaccine during the LTE trial.
6. Female participants of childbearing potential who are unwilling to use the contraceptive method specified in the trial protocol during treatment and for an additional 12 weeks after receiving the last dose of the investigational drug.
7. Female participants who are breastfeeding or plan to breastfeed during the trial and for 12 weeks after receiving the last dose of the investigational drug.
8. Female participants who plan to become pregnant or donate eggs during the trial and for 12 weeks after receiving the last dose of the investigational drug.
9. Female participants of childbearing potential who have a positive pregnancy assessment result on day 1 of a high-sensitivity urine pregnancy test.
10. Male participants with a female partner of childbearing potential who are unwilling to abstain from sexual intercourse (avoiding heterosexual activity) or use contraception during treatment and for an additional 12 weeks after receiving the last dose of the investigational drug.
11. Male participants with a pregnant partner who are unwilling to abstain from sexual intercourse or use condoms during treatment and for an additional 12 weeks after receiving the last dose of the investigational drug.
12. Male participants who do not wish to avoid sperm donation during treatment and for an additional 12 weeks after receiving the last dose of the investigational drug.
13. Participants with a known allergy to any drug or ingredient administered during the treatment period.
14. Participants who, to the best of the participant's and the trial administrator's knowledge, may be unable to complete all trial follow-up visits or procedures required by the trial protocol, and/or comply with all necessary trial procedures (e.g., clinical outcome assessment).
15. Any other clinically significant medical history, condition, or disease (other than those listed above) that, in the judgment of the trial administrator or Amgen physician (if consulted), poses a risk to the participant's safety or interferes with trial assessment, procedures, or completion.
The Estimated Number of Participants
-
Taiwan
21 participants
-
Global
844 participants
